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Legal Issues Involved in Tissue Engineering: FDA Regulation of Tissue Engineering

  • William H. Kitchens
Chapter

Abstract

Emerging therapies involving cell and genetic materials and their commercial development challenge the limits of the U.S. Food and Drug Administration’s (FDA) regulation of these products as drugs, medical devices, and biologic products. Existing FDA statutory authorities, although enacted prior to the advent of tissue engineering, have been used by FDA to encompass a regulatory scheme for these new products and to require that areas such as safety, efficacy, quality control, and potency be thoroughly addressed prior to marketing. In a rapidly evolving field like cell and gene therapy, regulatory policies and approaches can be expected to change as new products are developed and experience accumulates; however, some general observations can be made about the agency’s current regulatory strategies in this area.

Keywords

Cord Blood Stem Cell Stem Cell Product Investigational Device Exemption Premarket Approval Gene Therapy Product 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

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Copyright information

© Birkhäuser Boston 1997

Authors and Affiliations

  • William H. Kitchens
    • 1
  1. 1.Arnall Golden & Gregory2800 One Atlantic CenterAtlantaUSA

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